Brand name · Trisodium citrate dihydrate
Anticoagulant Sodium Citrate: adverse event reports filed with FDA
6,781 reports list it as a suspect or interacting product, 2005–2026. Class: Anti-coagulant. Also reported as Anticoagulant Sodium Citrate Solution 250 Ml.
- 6,781
- reports as suspect product
- 0% of all reports · about 327 a year
- 80
- reports, 12 months to June 2026
- 225 in the 12 months before
- 2.4%
- marked serious by the reporter
- 55.7% across the class
- 0.8%
- record death among outcomes, as reported
- 56 reports · not verified by FDA
6,781 adverse event reports received by FDA list the brand name Anticoagulant Sodium Citrate (trisodium citrate dihydrate) as a suspect or interacting product, from October 2005 to February 2026. A further 37 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 80 reports listed it, down 64% from 225 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 327 reports a year and 0% of the 20,646,523 reports in the database, and 23.4% of the reports for the anti-coagulant class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are paraesthesia (84%), nausea (44.5%) and dizziness (43.8%). A report can list several reactions, so shares add to more than 100%; 168 different terms appear across these reports. Paraesthesia is recorded in 84% of these reports, a larger share than in the median anti-coagulant drug (0.4%).
2.4% of the reports are marked serious by the reporter (55.7% across the class); 0.8% record death among the outcomes and 0.9% record hospitalisation, as reported. 99.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (80.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Anticoagulant Sodium Citrate reports recording the termmedian drug in anti-coagulant
- Paraesthesiatingling or pins and needles84%5,693
- Nauseafeeling sick44.5%3,018
- Dizzinesslight-headedness or unsteadiness43.8%2,967
- Feeling hotfeeling hot42.7%2,896
- Pallor39.2%2,657
- Hyperhidrosisexcessive sweating34.1%2,310
- Astheniaweakness or lack of energy20.1%1,363
- Thirst19.8%1,340
- Vision blurredblurred vision17.5%1,190
- Dysgeusiaaltered taste17.2%1,165
- Chillschills or shivering11.1%755
- Dyspepsiaindigestion10.5%710
- Restlessnessrestlessness8.5%573
- Hypoaesthesianumbness7.8%530
- Muscle spasmsmuscle cramps7.6%516
- Abdominal painstomach or belly pain6.5%441
- Painpain, site not specified5%338
- Confusional stateconfusion4.3%294
- Tetany3.8%255
- Palpitationsawareness of the heartbeat3.7%251
- Injection site haematoma3.6%242
- Headachehead pain3.4%231
- Neck painneck pain3.3%226
- Paraesthesia oral2.3%158
- Anxietyanxiety2.1%140
- Vomitingbeing sick2%134
- Hypoaesthesia oral1.8%123
- Movement disorder1.6%109
- Cold sweat1.4%95
- Dyspnoeashortness of breath1.4%94
Top 30 of 168 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 10 drugs in the anti-coagulant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 28,971 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Anticoagulant therapy | 6,712 | 99% |
| Thrombosis | 41 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,781 reports.
In context
| Measure | Anticoagulant Sodium Citrate | Anti-coagulant | All reports |
|---|---|---|---|
| Reports as suspect product | 6,781 | 28,971 | 20,646,523 |
| Share of that pool | — | 23.4% | 0% |
| Reports, latest 12 months | 80 | — | 1,332,454 |
| Marked serious | 2.4% | 55.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 172 | 91 |
| Hospitalisation recorded, per 1,000 reports | 9 | 238 | 213 |
| Consumer-filed share | 0% | 10.2% | 45.8% |
| Top term, share of reports | Paraesthesia 84% | median 0.4% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the anti-coagulant class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Heparin sodium | generic | 13,350 | 845 | 68% |
| Fragmin | brand | 3,327 | 220 | 79.1% |
| Dalteparin sodium | generic | 1,298 | 63 | 95.5% |
| Argatroban | generic | 1,062 | 52 | 85.1% |
| Bivalirudin | generic | 706 | 41 | 90.7% |
| Sodium citrate | generic | 624 | 44 | 95.2% |
| Potassium citrate | generic | 616 | 64 | 41.4% |
| Clenpiq | brand | 616 | 31 | 17.4% |
| Heparin Sodium in Dextrose | brand | 591 | 24 | 88.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Anticoagulant Sodium Citrate reports
How many adverse event reports has FDA received for Anticoagulant Sodium Citrate?
6,781 reports list Anticoagulant Sodium Citrate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 80 of them arrived in the latest 12 months. Another 37 list it only as a concomitant medication.
What reactions are recorded in Anticoagulant Sodium Citrate reports?
paraesthesia (84%), nausea (44.5%), dizziness (43.8%), feeling hot (42.7%) and pallor (39.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Anticoagulant Sodium Citrate was responsible.
How serious are the reports?
2.4% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 0.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (99.8%), not given (0.1%) and physician (0%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Anticoagulant Sodium Citrate rising?
80 reports in the 12 months to June 2026, down 64% from 225 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Anticoagulant Sodium Citrate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Anticoagulant Sodium Citrate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Anticoagulant Sodium Citrate as a suspect or interacting product; reports listing it only as a concomitant medication (37) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.